QHX — Fluoroscopic X-Ray Image Intensifier Class I

FDA Device Classification

FDA product code QHX covers "Fluoroscopic X-Ray Image Intensifier", a Class I medical device regulated under 21 CFR 892.1960. Submissions are reviewed by the Radiology panel.

Classification Details

Product Code
QHX
Device Class
Class I
Regulation Number
892.1960
Submission Type
Review Panel
RA
Medical Specialty
Radiology
Implant
No

Definition

To instantaneously convert an x-ray pattern from a fluoroscopic x-ray system into a corresponding light image of higher energy density.